Group CBT for Aggression in Veterans

NCT02233517 | Completed Results

• 2 other identifiers: D1298-W1IK2RX001298-01A2
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Posttraumatic stress disorder (PTSD) robustly predicts anger and aggression, and U.S. Iraq/Afghanistan-era combat Veterans report that treatment for anger and aggression is among their top priorities. PTSD-related anger and aggression are associated with profound functional impairments, yet to date there are no empirically-supported treatments for Veterans with PTSD and aggression. Effective group treatment programs could improve functioning and facilitate community reintegration for these Veterans. Given that anger impedes progress in treatment of PTSD symptoms, group anger treatment could also improve Veterans' capacity to benefit from individually-administered empirically-supported therapy for PTSD such as prolonged exposure or cognitive processing therapy.

Conditions

Aggression; Anger; Posttraumatic Stress Disorder

Keywords

Veterans; Cognitive-Behavioral Therapy; Aggression; Anger; Posttraumatic Stress Disorder; Combat Disorders

Outcome Measures

Primary Outcomes (3)

• Change in Mean Scores on the Conflicts Tactics Scale (CTS) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up.

  Physically aggressive behaviors including throwing something at someone, pushing, grabbing, shoving, slapping, kicking, biting, hitting, beating up, threatening with a gun or knife, or using a gun or knife on someone. Scale range 0 (never) to 6 (more than 20 times) over past 30 days.

  pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)

• Change in Mean Scores on the Dimensions of Anger Reactions Scale (DAR) Over 16 Time Points: Baseline, 12 Treatment Sessions, Post-treatment, 3-month and 6-month Follow-up

  The DAR is a 7-item scale measuring the frequency, duration, and behavioral response to anger, and anger-related functional impairment on social relationships, health, and work. The scale will be administered weekly to provide information about the pattern of change in anger- and aggression-related cognitions over the course of the group. Scores range from 0 to 56, with higher scores reflecting greater impairment.

  pre-treatment (baseline), weekly treatment sessions, post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)

• Change in Mean Scores on the Novaco Anger Scale (NAS) From Baseline to Post-treatment, 3-month Follow-up, and 6-month Follow-up.

  The NAS is a measure anger and coping that indexes four aspects of the experience of anger: Cognitive, Arousal, Behavior, and Anger Regulation. The T-score for the total NAS is used as the outcome, with a range of 0 to 100. Higher scores reflect greater impairment.

  pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)

Secondary Outcomes (4)

• Change in Mean Scores on the Community Reintegration of Service Members Computer Adaptive Test From Baseline to Post-treatment.

  pre-treatment (baseline), post-treatment (12 weeks)

• Change in Mean Scores on the World Health Organization Disability Assessment Schedule, Version 2.0 (WHO-DAS 2.0) Over 16 Time Points: Baseline, 12 Treatment Sessions, Post-treatment, 3-month and 6-month Follow-up.

  pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)

• Change in Mean Scores on the Inventory of Psychosocial Functioning (IPF) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up.

  pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)

• The McMaster Family Assessment Device (FAD)

  pre-treatment, post-treatment, 3 months post-treatment, 6-months post-treatment

Other Outcomes (4)

• The Adaptability Scale of the Connor-Davidson Resilience Scale (CD-RISC)

  pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)

• PTSD Checklist (PCL)

  pre-treatment (baseline), post-treatment (12 weeks)

• The Alcohol Use Disorder Identification Test (AUDIT)

  pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)

Study Arms (2)

Cognitive Behavioral Therapy

EXPERIMENTAL

Cognitive-Behavioral Therapy for Anger and Aggression in Combat Veterans with PTSD (CBT-A) is a 12-week manualized group treatment protocol that is grounded in up-to-date research, and that specifically addresses the Energy and Drive Functions, Attention Functions, Emotion Functions, and Thought Functions that are hypothesized to underlie the limitations to Activities and Participation associated with PTSD-related anger and aggression. Each session lasts 90 minutes. The first session orients participants to the structure and philosophy of the program, provides a historical overview of PTSD, and introduces the concept of the "survival mode" of functioning (Chemtob et al., 1997). The remaining 11 sessions follow a standard format: 1) practice relaxation training (15-20 minutes); 2) review homework, introduce new material, and engage in group activities focused on implementing new skills and behaviors (70-80 minutes); and 3) review problems or concerns of group members.

Behavioral: Cognitive Behavioral Therapy

Present Centered Therapy

ACTIVE COMPARATOR

Present Centered Therapy (PCT) is an active, manualized treatment comparison condition for psychotherapy trials. PCT is designed to control for nonspecific factors of therapy such as contact with a trained therapist, rationale for treatment, and instillation of expectancy for therapeutic gains. The therapeutic approach was drawn from Yalom's group therapy model, which utilizes interpersonal process, supportive techniques, identification of response options, encouragement of adaptive reactions, and focus on the "here-and-now". Previous large-scale randomized clinical trials of Veterans with PTSD have found reduced PTSD symptoms in the PCT comparison condition (Schnurr et al., 2003), and a survey of practice patterns within the VA suggests that similar present-focused approaches are routinely employed by VA mental health providers (Rosen et al., 2004). Consistent with recommendations in the PCT manual, training will emphasize the approach rather than specific interventions.

Behavioral: Present Centered Therapy

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

Cognitive Behavioral Therapy provides patients with the skills to 1) identify and challenge maladaptive cognitions that are contributing to self-destructive behaviors; and 2) implement techniques such as relaxation training, communication skills, and relaxation training to address physiological and environmental barriers to effective functioning.

Cognitive Behavioral Therapy

Present Centered Therapy BEHAVIORAL

Present Centered Therapy utilizes interpersonal process, supportive techniques, identification of response options, encouragement of adaptive reactions, and focus on the "here-and-now" to support patients in their efforts to improve functioning.

Present Centered Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current PTSD based on the CAPS;
• served in combat (regardless of era or country of combat service);
• can speak and write fluent conversational English;
• at least 18 years of age;

You may not qualify if:

• A Veteran will be excluded from participation if he/she:
• is expected to be unstable on his/her medication regimen during the study;
• currently meets criteria for Bipolar I Disorder or a primary psychotic disorder as determined by the Structured Clinical Interview for the DSM (most current version available) (SCID);
• is receiving (or plan to) other anger-management psychotherapy during the course of the study;
• will be undergoing empirically supported psychotherapy for PTSD during the treatment component of the study;
• meets criteria for substance dependence (other than nicotine) within the past month as determined by the SCID; or
• is determined to have moderate or severe impairment related to traumatic brain injury as measured by the Brief Traumatic Brain Injury Screen and consultation with the Veteran's provider.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

Related Publications (6)

• Dennis PA, Dennis NM, Van Voorhees EE, Calhoun PS, Dennis MF, Beckham JC. Moral transgression during the Vietnam War: a path analysis of the psychological impact of veterans' involvement in wartime atrocities. Anxiety Stress Coping. 2017 Mar;30(2):188-201. doi: 10.1080/10615806.2016.1230669. Epub 2016 Sep 19.

  PMID: 27580161 BACKGROUND

• Van Voorhees EE, Dennis PA, Neal LC, Hicks TA, Calhoun PS, Beckham JC, Elbogen EB. Posttraumatic Stress Disorder, Hostile Cognitions, and Aggression in Iraq/Afghanistan Era Veterans. Psychiatry. 2016 Spring;79(1):70-84. doi: 10.1080/00332747.2015.1123593.

  PMID: 27187514 BACKGROUND

• Van Voorhees EE, Dennis PA, Elbogen EB, Clancy CP, Hertzberg MA, Beckham JC, Calhoun PS. Personality assessment inventory internalizing and externalizing structure in veterans with posttraumatic stress disorder: associations with aggression. Aggress Behav. 2014 Nov-Dec;40(6):582-92. doi: 10.1002/ab.21554. Epub 2014 Aug 16.

  PMID: 25131806 BACKGROUND

• Ulmer CS, Van Voorhees E, Germain AE, Voils CI, Beckham JC; VA Mid-Atlantic Mental Illness Research Education and Clinical Center Registry Workgroup. A Comparison of Sleep Difficulties among Iraq/Afghanistan Theater Veterans with and without Mental Health Diagnoses. J Clin Sleep Med. 2015 Sep 15;11(9):995-1005. doi: 10.5664/jcsm.5012.

  PMID: 26094928 BACKGROUND

• Van Voorhees EE, Beckham JC. Advancements in treating intimate partner violence in veterans. J Clin Psychiatry. 2015 Jun;76(6):e826-7. doi: 10.4088/JCP.14com09556. No abstract available.

  PMID: 26132696 BACKGROUND

• Tye S, Van Voorhees E, Hu C, Lineberry T. Preclinical perspectives on posttraumatic stress disorder criteria in DSM-5. Harv Rev Psychiatry. 2015 Jan-Feb;23(1):51-8. doi: 10.1097/HRP.0000000000000035.

  PMID: 25563569 BACKGROUND

MeSH Terms

Conditions

Aggression; Stress Disorders, Post-Traumatic; Combat Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Elizabeth Van Voorhees
• Organization: VAORD

elizabeth.vanvoorhees@va.gov

(919) 286-0411

Study Officials

• Elizabeth E Van Voorhees, PhD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: September 8, 2014
• Study Start: February 9, 2015
• Primary Completion: July 5, 2017
• Study Completion: July 5, 2017
• Last Updated: May 31, 2019
• Results First Posted: May 31, 2019

Record last verified: 2019-05

Locations

US (1)